My Health Coach App for Fetal Alcohol Spectrum Disorders

Overseen By Christie L. M. Petrenko, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Past trial participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the My Health Coach App treatment for Fetal Alcohol Spectrum Disorders?

Research shows that smartphone apps can effectively reduce alcohol consumption in various groups, such as college students and individuals with alcohol use disorder. These apps have been found to help users manage their drinking habits, suggesting that similar technology could be beneficial for addressing alcohol use during pregnancy. ^{1 2 3 4 5}

Is the My Health Coach App for Fetal Alcohol Spectrum Disorders safe for use?

There is no specific safety data available for the My Health Coach App for Fetal Alcohol Spectrum Disorders. However, general concerns about the credibility and safety of content within mobile health apps have been noted, especially for apps targeting pregnancy and health behavior changes. ^{6 7 8 9 10}

How does the My Health Coach App treatment differ from other treatments for Fetal Alcohol Spectrum Disorders?

The My Health Coach App is unique because it leverages mobile health technology to support lifestyle changes and health prevention behaviors, which is different from traditional treatments that may not use digital tools. This app-based approach can help users take control of their health by providing continuous support and information, which is not typically available in standard treatments for Fetal Alcohol Spectrum Disorders. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this clinical trial is to learn if the My Health Coach app helps adults with fetal alcohol spectrum disorders (FASD). The main questions it aims to answer are: Does the My Health Coach app improve the quality of life of adults with FASD? Does the My Health Coach app help adults with FASD manage their day to day life? All participants will be asked to complete 3 sets of surveys: 1) at the study start, 2) at 6 weeks, and 3) at 12 weeks. Half of the participants will be given the app at the study start to use. The other half of participants will get the app after the 12 week surveys are complete. Researchers will compare survey results from people who receive the app right away to those who are in the waitlist group to see if there are changes in quality of life or day to day functioning.

Eligibility Criteria

This trial is for adults over 18 with fetal alcohol spectrum disorders (FASD) or a history of prenatal alcohol exposure. Participants must be fluent in English and own a smartphone. It's not specified who can't join, but typically those with conditions affecting participation would be excluded.

Inclusion Criteria

I have been diagnosed with FASD or was exposed to alcohol before birth.

I can read and write in English well.

I own a smartphone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete the initial set of surveys to assess baseline measures

1 week

1 visit (virtual)

Treatment

Participants in the My Health Coach group use the app, while the waitlist group does not receive the app

12 weeks

2 visits (virtual) at 6 and 12 weeks

Follow-up

Participants are monitored for changes in quality of life and day-to-day functioning

4 weeks

Treatment Details

Interventions

• My Health Coach App

Trial Overview The My Health Coach app is being tested to see if it improves quality of life and daily management for adults with FASD. The study involves completing surveys at the start, after 6 weeks, and after 12 weeks. Some get the app immediately; others wait until after the final survey for comparison.

Participant Groups

Group I: My Health Coach App Group Experimental Treatment 1 Intervention

The My Health Coach group receives the My Health Coach app at study start. The My Health Coach app is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.

Group II: Waitlist Control Group Active Control 1 Intervention

The Waitlist Control Group gets access to the My Health Coach app after all the study survey timepoints are complete at 12 weeks.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Findings from Research

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

This study aims to evaluate the effectiveness of a technology-delivered Screening and Brief Intervention (SBI) for pregnant women with unhealthy alcohol use, using a factorial design to assess various intervention strategies.

The primary goal is to measure alcohol abstinence in participants, with secondary outcomes including the impact of tailored text messages and the intervention's effects on birth outcomes, ensuring a comprehensive approach to addressing prenatal alcohol exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. Ondersma, SJ., Todd, L., Jablonski, S., et al.[2023]

The interactive, video-enhanced e-SBI (electronic screening and brief intervention) was found to be highly acceptable among pregnant women, with participants rating it as easy to use and helpful, scoring between 4.7 to 5.0 on a 5-point scale.

The pilot trial suggested medium-sized effects of the e-SBI on achieving 90-day period prevalence abstinence from alcohol and improved pregnancy outcomes, with odds ratios of 3.4 and 3.3 respectively, indicating potential benefits that warrant further investigation in a larger study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. Ondersma, SJ., Beatty, JR., Svikis, DS., et al.[2018]

The 'Quest' app, designed for relapse prevention in patients with alcohol dependence syndrome, received high usability (5.8 out of 7) and acceptability (65%) ratings from users, indicating it is user-friendly and well-received.

While both groups (those using the Quest app and those receiving standard treatment) showed a significant reduction in drinking days over three months, there was no notable difference in relapse rates or heavy drinking days between the two groups, suggesting the app's effectiveness needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. Sharma, AK., Shadakshari, D., Chand, P., et al.[2023]

A review of 370 smartphone apps for child nutrition identified 33 that qualified for analysis, revealing that many lack updated information and do not cite their sources, which raises concerns about the reliability of the guidance provided to parents.

Only a small number of apps offer expert consultations or specific nutrient requirements, indicating a lack of uniform guidelines in the development of these applications, which could affect their effectiveness in supporting child nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. Srivastava, R., Kushwaha, S., Khanna, P., et al.[2022]

A scoping review of 16 studies found that pregnancy-specific apps often lack transparency and credibility regarding the information they provide, which raises safety concerns for users.

Key safety considerations identified include the need for better protection of personal data, the importance of evidence-based content, and the necessity for apps to be tailored to local guidelines and users' digital health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. Carrandi, A., Hayman, M., Harrison, CL.[2023]

In a pilot study involving 36 pregnant adolescents, the use of wrist-worn accelerometers to assess physical activity was found to be neither feasible nor acceptable, with only 51.5% achieving the minimum of 4 days of valid wear.

Participants rated the acceptability of accelerometer use as neutral, suggesting that future research should explore better incentives and possibly lower wear-time requirements to improve adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Accelerometer Measurement of Physical Activity in Pregnant Adolescents. Clark, ELM., Gulley, LD., Hilkin, AM., et al.[2022]

A systematic evaluation of seven DASH diet apps revealed that only two apps, NOOM and DASH To TEN, met both quality and data security standards, making them suitable for supporting self-management of the DASH diet.

While three apps scored high in quality across various domains, most apps exhibited significant shortcomings in quality and data privacy, highlighting the need for better app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. Alnooh, G., Alessa, T., Noorwali, E., et al.[2023]

A systematic review of 27 studies found that health and fitness apps can lead to significant improvements in diet, physical activity, and sedentary behavior, particularly in adults, with 17 out of 23 adult-targeted studies showing positive health outcomes.

Multi-component interventions that include apps were more effective than stand-alone app interventions, suggesting that combining app features with other strategies may enhance user engagement and health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review. Schoeppe, S., Alley, S., Van Lippevelde, W., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Accelerometer Measurement of Physical Activity in Pregnant Adolescents. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Design of a Mobile App for Nutrition Education (TreC-LifeStyle) and Formative Evaluation With Families of Overweight Children. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A review of pregnancy iPhone apps assessing their quality, inclusion of behaviour change techniques, and nutrition information. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review. [2022]

13. England pubmed.ncbi.nlm.nih.gov

CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Eating for 2: A Systematic Review of Dutch App Stores for Apps Promoting a Healthy Diet during Pregnancy. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Characterising the use, users and effects of a health app supporting lifestyle changes in pregnant women. [2023]